Expired Study
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San Francisco, California 94109


Purpose:

To assess the safety and tolerance of curdlan sulfate, as well as its anti-HIV activity, in HIV-infected patients with CD4 T-lymphocytes less than 500 cells/mm3, using first single doses and then, after FDA review, daily doses for 7 days.


Study summary:

In Phase I of the study, escalating single doses of intravenous curdlan sulfate are tested. In Phase II, curdlan sulfate is administered daily for 7 days. (NOTE: Phase I is completed.)


Criteria:

Inclusion Criteria Patients must have: - HIV seropositivity. - No current AIDS-defining opportunistic infection, lymphoma, Kaposi's sarcoma, or other malignancy. - CD4 count < 500 cells/mm3. - No critical illness that would shorten life expectancy to < 16 weeks. Exclusion Criteria Concurrent Medication: Excluded: - Antiretroviral or other experimental therapies. - Anticoagulants. - Steroids. - Cytotoxic or immunosuppressive agents. Concurrent Treatment: Excluded: - Radiotherapy. Patients with the following prior condition are excluded: History of heparin sensitivity. Prior Medication: Excluded within 1 month prior to study entry: - Antiretroviral or other experimental therapies. - Anticoagulants. - Steroids. - Cytotoxic or immunosuppressive agents. Prior Treatment: Excluded: - Radiotherapy within 1 month prior to study entry. Active IV drug abuse.


Study is Available At:


Original ID:

127A


NCT ID:

NCT00002100


Secondary ID:

LCPL 92-1-28


Study Acronym:


Brief Title:

Phase I/II Study of Curdlan Sulfate


Official Title:

Phase I/II Study of Curdlan Sulfate


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Primary Pu


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:April 1994
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Curdlan sulfate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:AJI Pharma USA

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Gordon M, Guralnik M, Kaneko Y, Mimura T, Baker M, Lang W. A phase I study of curdlan sulfate--an HIV inhibitor. Tolerance, pharmacokinetics and effects on coagulation and on CD4 lymphocytes. J Med. 1994;25(3-4):163-80.
PMID:7996061

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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